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Active, Not Recruiting

NCT Number: NCT06230224

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug versus Standard of Care (SOC) * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

B-cell Non-Hodgkin Lymphoma (B-NHL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundaleu - Fundacion Para Combatir La Leucemia, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
  • Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
  • Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
  • Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate hematologic and organ function.

Key Exclusion Criteria:

  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
  • History of or current relevant CNS pathology, as described in the protocol
  • A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
  • Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol
  • Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
  • Allergy/hypersensitivity to study drug, or excipients.

NOTE: Other protocol defined inclusion / exclusion criteria apply

Treatment and study plan

Odronextamab

Drug

Administered by intravenous (IV) infusion

Other names: R1979

ifosfamide

Drug

Administered by IV infusion, as part of the ICE ± R salvage therapy

Other names: Ifex

carboplatin

Drug

Administered by IV infusion, as part of the ICE ± R salvage therapy

Other names: Paraplatin

etoposide

Drug

Administered by IV infusion, as part of the ICE ± R salvage therapy

Other names: Etopophos

Rituximab

Drug

Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.

Other names: Rituxan

Dexamethasone

Drug

Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.

Other names: Decadron

Cisplatin

Drug

Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.

Other names: Platinol

Cytarabine

Drug

Administered by IV infusion, as part of the DHAP ± R salvage therapy.

Other names: Cytosar-U

Gemcitabine

Drug

Administered by IV infusion, as part of the GDP ± R salvage therapy.

Other names: Gemzar

Primary outcomes

  1. Event-free survival (EFS) as assessed by independent central review (ICR)

    Time frame: Assessed up to 3 years

Secondary outcomes

  1. Progression free survival (PFS) as assessed by ICR

    Time frame: Assessed up to 3 years

  2. Best overall response (BOR) as assessed by ICR

    Time frame: Assessed up to 6 months

  3. Overall survival (OS)

    Time frame: Assessed up to 3 years

  4. Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30)

    Time frame: Assessed up to 3 years

    The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

  5. EFS as assessed by local investigator

    Time frame: Assessed up to 3 years

  6. PFS as assessed by local investigator

    Time frame: Assessed up to 3 years

  7. BOR as assessed by local investigator

    Time frame: Assessed up to 6 months

  8. Complete response (CR) as assessed by ICR

    Time frame: Assessed up to 6 months

  9. CR as assessed by local investigator

    Time frame: Assessed up to 6 months

  10. Duration of response (DOR) assessed by ICR

    Time frame: Assessed up to 3 years

  11. DOR assessed by local investigator

    Time frame: Assessed up to 3 years

  12. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Assessed up to 1 year

  13. Severity of TEAEs

    Time frame: Assessed up to 1 year

  14. Odronextamab concentrations in serum

    Time frame: Assessed up to 6 months

  15. Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration

    Time frame: Assessed up to 6 months

  16. Titers of ADAs to odronextamab over the study duration

    Time frame: Assessed up to 6 months

  17. Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration

    Time frame: Assessed up to 6 months

  18. Measurable residual disease (MRD) status

    Time frame: Assessed up to 6 months

  19. Overall change in patient-reported outcomes (PROs), as measured by scores of the EORTCQLQ- C30

    Time frame: Assessed up to 3 years

    The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

  20. Overall change in PROs, as measured by scores of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)

    Time frame: Assessed up to 3 years

    The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

  21. Overall change in PROs, as measured by scores of the EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)

    Time frame: Assessed up to 3 years

    The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".

  22. Overall change in score of the Global Population item 5 (GP5) of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire

    Time frame: Assessed up to 3 years

    A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

Acronym: OLYMPIA-4

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jan 30, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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